Recommendation based on positive results from the DESTINY-Breast01 trial, which showed durable responses in patients with previously treated disease
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s trastuzumab deruxtecan has been recommended for conditional marketing authorisation in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens.
In Europe, approximately 520,000 cases of breast cancer in women are diagnosed annually, with roughly one in five cases being HER2 positive.
1-2 The impact of the disease is significant, with breast cancer responsible for more than 137,000 deaths per year.
Under-recognition of Symptoms May Be Common in Breast Cancer Patients Receiving Radiation
Symptom under-recognition may be more common among younger patients and Black patients
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December 14, 2020 Among patients with breast cancer treated with radiotherapy, under-recognition of symptoms was common in reports of pain, pruritus, edema and fatigue, with younger patients and Black patients having significantly increased odds of symptom under-recognition, according to data presented at the 2020 San Antonio Breast Cancer Symposium, held Dec. 8-11. Recognizing side effects is necessary for physicians to provide supportive care to help patients manage their symptoms, said Reshma Jagsi, M.D., D.Phil, the Newman Family Professor and deputy chair of the Department of Radiation Oncology and director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan.
Pregnancy Less Common in Young Breast Cancer Survivors medpagetoday.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medpagetoday.com Daily Mail and Mail on Sunday newspapers.
Estrogen receptor (ER) is present in 85% of all breast cancers, and more than 90% of ER+ positive breast cancers also contain the AR which has been demonstrated to be an important therapeutic target in ER+ breast cancer. Enobosarm is an oral drug that selectively targets the AR in breast cancer without having the unwanted virilizing androgen adverse side effects including facial hair, acne, increase in hematocrit, or liver toxicity, while having potential clinical benefits including increasing muscle and physical function as well addressing cancer treatment induced bone loss and fractures. Enobosarm has extensive nonclinical and clinical experience having been evaluated in 25 separate clinical studies with 2,091 enrolled patients, including three Phase 2 clinical studies in advanced breast cancer. There are also at least two enobosarm investigator-initiated Phase 2 clinical studies in advanced breast cancer.
Lancet Oncology. In the DESTINY-Breast01 trial, trastuzumab deruxtecan demonstrated clinically meaningful and durable activity in patients who had received two or more prior anti-HER2 therapies. The safety and tolerability profile of trastuzumab deruxtecan seen in DESTINY-Breast01 was consistent with that observed in the phase 1 trial.
An updated analysis from DESTINY-Breast01, reinforcing the durable efficacy and long-term safety and tolerability profile of trastuzumab deruxtecan, was presented earlier this week at the 2020 San Antonio Breast Cancer Symposium (SABCS).
“We are encouraged by the CHMP positive opinion given the significant unmet need for patients with HER2 positive metastatic breast cancer,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “Trastuzumab deruxtecan is already available for patients with HER2 positive metastatic breast cancer in the U.S. and Japan, and we are now one st